How to Think Outside the Checkboxes of Risk Management

Risk management strategy should be about more than a series of checkboxes on a regulatory form. Consultant Mike Drues encourages his clients to think outside the checkboxes to create a risk management plan that makes sense from an engineering and biology perspective.

All medical device companies have some form of risk management plan, but not all risk management plans are created equal.

"In my opinion, most all of them do a pretty horrific job at it," said Mike Drues, president of Vascular Sciences.

Drues, a regulatory consultant, shared some of his views on current risk management strategy in the industry, and his advice for companies developing a risk management plan, during an interview with Qmed.

"Unfortunately, when it comes to a lot of regulatory and related topics, to a lot of people it's a series of checkboxes on a form," Drues said. "And anybody who takes that approach in this business should absolutely not be in this business."

Grafton, MA-based Vascular Sciences offers consulting and educational services to medical device, pharmaceutical, and biotech companies on a range of topics, including regulatory strategy, and FDA presentation preparation and defense.

Risk management is a constant source of problems in the device industry, Drues said. Of course, the industry has standards in place that are supposed to help companies navigate risk management issues, but Drues said most of these standards come up short.

"After playing this game now myself for 25 years, I've come up with what I think is a better approach," Drues said. That's not to say it's a perfect approach, he added, but it does seem to be catching on.

He advocates doing what makes sense from an engineering and biology perspective - not from a regulatory and quality perspective.

There are aspects of risk that go into a regulatory submission for a de novo, a 510(k) clearance, or even a pre-market approval application, Drues said, that are not even hinted at in the quality or design control.

During his presentation at BIOMEDevice Boston, Drues will talk about the differences between design control risk and regulatory risk.

"Some companies fear the FDA, but they should not fear FDA, they should have a healthy respect for FDA," Drues said. "Who they should fear is the product liability attorneys."

And while President Donald Trump and his nominee for FDA commissioner, Scott Gottlieb, have talked about cutting FDA's regulation by 70% to 80%, Drues said that's the wrong thing to be focusing on.

Instead of asking if there is too much regulation at the agency, the question should be if the regulation that is there make sense, Drues said.

"What does it accomplish in the real world? Because every single day, I run into regulation that makes absolutely no sense," he said.